U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Guide, surgical, instrument - Product Code FZX
원인
May have difficulty attaching the drill sleeve to the plate. if the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. if the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
조치
In August of 2017 customers were mailed an URGENT FIELD SAFETY NOTICE titled "884115 - Locking Compression Plate (LCP) Drill Sleeve" requesting that customers who received product subject to recall to please contact: RA-DPYCH-flactionint@ITS.JNJ.com or call 610-719-5450.
In the event that you have product requiring use:
Pre-assemble the drill sleeve with the plate preoperatively. If you experience difficulty connecting the drill sleeve to the plate, use the additional 1.1 mm locking drill sleeve provided in the graphic case, or:
o Align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner.
o If the drill hole must be used and no option to lock remains, a non-locking screw can be used.
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 || Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments